GDUFA Research Outcomes

PBPK Models

This section contains scientific publications, presentations, and posters arising from GDUFA-funded research relevant to physiologically-based pharmacokinetics (PBPK) computational modeling to support generic product development and assessment.

• All(475)
• Posters(107)
• Presentations(231)
• Papers(137)

• Integration of Physicochemical Product Characteristics within a Mechanistic Dermal PBPK Model to Support Virtual Bioequivalence Evaluation of Topical Drug Products: A Case Study with Acyclovir Topical Creams

  Martins, Frederico; Patel, Nikunjkumar; Salem, Farzaneh; Jamei, Masoud; Polak, Sebastian

• Mechanistic Modelling Of Dermal Drug Absorption Using The Simcyp Multi-Phase Multi-Layer Mechderma Model: Case Study Of A Transdermal Patch Formulation Of Weak Base Drug Timolol

  Patel, Nikunjkumar; Cristea, Sinziana; Rose, Rachel; Salem, Farzaneh; Abduljalil, Khaled; Johnson, Trevor; Jamei, Masoud; Raney, Sam; Zhang, Xinyuan; Lin, Hopi; Newman, Bryan; Chow, Edwin; Ghosh, Priyanka; Fan, Jianghong; Fang, Lanyan; Polak, Se

• Towards Development And Validation Of The Dermal Pbpk Model For Virtual Bioequivalence -Model Description And Validation Case Studies

  Patel, Nikunjkumar; Cristea, Sinziana; Polak, Sebastian

• Modelling and Simulation of Corneocyte Swelling: A Theoretical Contribution on the Barrier Properties of the Skin

  Nagel, Arne; Scherer, Martin; Wittum, Gabriel

• Development Of An In Vitro Mechanistic Model That Describes Drug Release From Risperidone Long-Acting Injectable Microspheres

  Mullin, James; Lukacova, Viera; Woltosz, Walter; Bolger, Michael

• Simulation of in vitro Dissolution and Degradation of Orntide-loaded PLGA Microspheres

  Mullin, James; Van Osdol, William; Lukacova, Viera; Woltosz, Walter; Bolger, Michael

• Determination of CYP2D6 Phenotyping for Metoprolol using the Genotype-derived Activity Score

  Mosley, Scott; Frye, Reginald; Langaee, Taimour; Schmidt, Siegfried; Schmidt, Stephen; Gong, Yan; Binkley, Philip; Johnson, Julie; Cavallari, Larisa

• Using a Physiologically-based Pharmacokinetic Absorption Model for Biopharmaceutics to Establish Clinically Relevant Dissolution Safe Space for Oseltamivir in Adult and Pediatric Populations

  Miao, Lei; Wu, Fang; Zhao, Liang; Raines, Kimberly; Seo, Paul

• Cellular Pharmacokinetic/Pharmacodynamic Of Doxorubicin In A Wide Array Of Cell Lines.

  LeMerdy, Maxime; Hendriks, Bart; Cao, Yanguang

• Multi-phase Multi-layer MechDermA model: Development, Verification and Application of a PBPK-PD Model of Dermal Absorption for Transdermal Product Assessment

  Martins, Frederico; Patel, Nikunjkumar; Salem, Farzaneh; Jamei, Masoud; Polak, Sebastian